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US FDA's Breakthrough Program Needs Higher Standard For Comparators, NEJM Says

 
• By Michael Cipriano

Harvard Medical School researchers call for inclusion of off-label drugs, accelerated approvals, and dietary supplements in the definition of 'existing therapies.'

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Three Harvard Medical School researchers are calling for the US FDA to broaden the definition of "existing therapies" in the criteria for the breakthrough therapy designation to raise the comparison baseline and increase the bar to qualify for the designation.

In a study published in the New England Journal of Medicine (NEJM) on April 11 that examines the first four years of the breakthrough therapy designation program, Jonathan Darrow, Jerry...

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